Packaged concentrate thickener compositions

ABSTRACT

A process for thickening liquid food and/or medications of people with swallowing problems which involves dilution of a concentrate thickener paste which has been thickened to several times its normally useful and cost-effective levels. The approach is beneficial in formulations intended for radiological evaluations of people with swallowing problems including those persons suffering from dysphagia.

CROSS REFERENCE TO PRIOR APPLICATIONS

This application is a division of pending application Ser. No.10/485,879, filed Feb. 2, 2004, which is a national phase applicationunder 35 U.S.C. § 371 of Patent Cooperation Treatyapplication/PCT/US02/24525, Aug. 2, 2002, which claims the benefit ofU.S. provisional application 60/309,764 filed Aug. 2, 2001, all of whichare incorporated herein in their entirety by reference.

BACKGROUND OF THE INVENTION

The present invention relates to concentrate thickener compositions.More particularly the invention relates to xanthan gum concentratecompositions.

Swallowing problems in humans include difficulty in swallowing,inability to swallow, and discomfort in swallowing. These problems arecollectively termed dysphagia. Dysphagia is a common unfortunatesecondary condition that accompanies many primary human disease statessuch as stroke, multiple sclerosis, asperger syndrome, esophagealcancer, laryngeal cancer, chagus disease, cystic fibrosis, Huntington'schorea, amyotrophic lateral sclerosis, Parkinson's disease, Riley-Daysyndrome, scleroderma, and Alzheimer's disease. In some instancesdysphagia occurs due to a birth defect. In pre-term infants, dysphagiamay occur simply because the musculature and anatomy involved inswallowing has not yet fully developed.

Dysphagia is pervasive as between about 5 and about 15 million people inthe United States suffer from dysphagia. People with dysphagia generallylack proper muscle control and coordination to properly seal thewindpipe or they lack the ability to properly propel the bolus of foodand/or beverage to the stomach. If this condition goes unnoticed,sufferers are prone to foodstuff(s) and beverages going into thesufferer's lungs rather than being routed properly to their stomach.When routing to the lungs occurs, the patient sufferer is at increasedrisk for growing unhealthy bacteria in the lungs which raises theprospect of aspiration pneumonia (with its accompanying attendant risksand hospitalization) and/or even fatal asphyxiation.

About 30% to about 50% of persons with dysphagia would benefit from athickened diet. Thin fluids like water move so rapidly through the humanswallowing process and they have the least body or texture. Controllingthe bolus with these fluids can be very difficult. Any delayed or slowedmovement and/or coordination during the swallowing process will morelikely be a problem with a thin fluid because it moves so quicklythrough the mouth and into the throat. The lack of body or texture meansthat thin fluids are less likely to create the stimulation necessary forproper swallowing in people with dulled swallowing sensation. Bythickening fluids intended to be eaten by a person afflicted withdysphagia, it is possible to slow the progress of the fluid through thethroat, to produce a bolus that is easier to control, and/or to increasethe body or texture of the fluid to increase the likelihood ofgenerating the necessary stimulation for proper swallowing. A majorbenefit of such thickened fluids and thickened compositions is that whenany fluid is left behind in the throat, its thickness will resistflowing into the windpipe. Future swallows can then move the fluid thatwas left behind into the stomach.

In institutions and homes where beverages are prepared for persons withdysphagia the mixing equipment used is typically less than ideal. Handmixing with forks, spoons, stirrers, whisks, etc. is common. Dispersionis also not ideal. The powder is often measured, dumped into thecontainer and then mixing started. At best, some people will add thepowder while mixing. Rapid and efficient hydration is nearly impossible.

Typical dry powder products include Thick-It® (Precision Foods, St.Louis, Mo. USA), Thicken Up® (Novartis Nutrition, Minneapolis, Minn.USA), and Thick & Easy® (Hormel Healthlabs, Austin, Minn. USA) drypowder thickeners. By using agglomerated forms and/or mixing them withother non-clumping powders, most of the powder forms available on themarket are designed to reduce clumping and to be more likely toefficiently hydrate with mixing by hand. As will be demonstrated later,these powders do not appear to rapidly become completely hydrated. Theydramatically continue to increase in viscosity for at least 90 minutes.In addition, these products adversely affect the taste and appearance ofbeverages so they are less appetizing to patients. For example, waterthickened with any of the three products above will be white in colorand taste very starchy. Also, beverages like soda pop, human breastmilk, beer and wine cannot be effectively thickened with these powders.Carbonated beverages foam almost uncontrollably when these powders areadded. Human breast milk contains enzymes that rapidly break thesepowders down. And they do not effectively thicken alcoholic beverages.

Dry powder has a potential for accidental ingestion prior todissolution. Ingestion of dry powder can lead to swelling and blockageof the throat (Federal Register Aug. 26, 1993, pp. 45194-45201). In itsfinal ruling on the labeling of over-the-counter drugs, the UnitedStates Food and Drug Administration clearly indicates that drythickeners in powdered form are a risk for causing esophagealobstruction. Adding to the risk, some of the patients with dysphagiahave impaired decision making as a result of their primary disease.

Pre-thickened water, juices, and tea are available from severalmanufacturers. For example, Thick & Easy® (Hormel Healthlabs, Austin,Minn. USA), NUTRA/Balance™ (Ross Products, Columbus, Ohio USA) andResource® (Novartis Nutrition, Minneapolis, Minn. USA) pre-thickenedproducts. Pre-thickened beverages have only a limited beverage selectionwhich includes little more than water, dairy (milk), apple juice, orangejuice, cranberry juice, and tea and do not come in all three thicknessesused by the industry. Using pre-thickened beverages is an imperfectsolution. Their use will still require the use of powder—either toincrease beverage variety or to achieve all of the standard industrythicknesses. The taste and visual properties of pre-thickened beveragesdoes little to improve on the powders. For example, most pre-thickenedwater has lemon flavor added to it to try and hide its unpleasing taste.

Current approaches to meeting the needs of people with dysphagia fallshort.

SUMMARY OF THE INVENTION

In one aspect a process is provided for preparing thickener in aconcentrate form that will be easily dispersed by fork or eating utensilor any other simple method of agitation such as shaking by hand or bymachine. The thickener concentrate consistently and rapidly thickensmost fluids that a patient with dysphagia would desire or have a need toconsume. This process provides a food thickener that is more palatableand more visually appealing, that is safer to have in the presence ofpatients with impaired decision making.

More specifically a process is provided for thickening a liquid foodwhich comprises admixing an effective amount of an aqueous concentratedxanthan gum thickener composition with a liquid food which is capable ofbeing thickened by a concentrated xanthan gum thickener composition.

In another aspect, an effective treatment for dysphagia is providedwhich comprises feeding a concentrate thickener composition containedwithin a food to a patient having the condition of dysphagia wherein thethickened liquid comprises a swallowable food.

In another aspect, a system for operating a medical facility is providedwhich possesses the capability of successfully treating personsafflicted with dysphagia wherein the system provides a thickened food(s)to a patient(s), wherein the thickened food(s) comprises a concentratethickener composition.

In another aspect, a method for caring for a dysphagia patient at homeor in an institution is provided by providing a thickened food of thisinvention wherein the thickened food comprises a concentrate thickenercomposition.

BRIEF DESCRIPTION OF THE DRAWINGS

Table A shows changes in actual viscosity in centipoises vs. time forhuman breast milk thickened with a currently available commercialproduct and a composition of the present invention.

FIG. 1 graphically illustrates changes in actual viscosity incentipoises vs. time for human breast milk thickened with a currentlyavailable commercial product and a composition of the present invention.

FIG. 2 graphically illustrates changes in indexed viscosity as afunction of time for human breast milk thickened with a currentlyavailable commercial product and a composition of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with an embodiment of the invention, an admixturecomprising a concentrate of thickener is prepared from thickener andwater. In an exemplary method the thickener is xanthan gum. Any qualitywater may be employed; however, an exemplary embodiment includes tappotable water.

In an aspect, a thickener or combinations thereof may be employed.Illustrative and nonlimiting examples of such thickeners are alginates(sodium, potassium, or ammonium salts thereof), carrageenan,glactomannans such as guar gum, locust bean gum, and/or carob bean gum,cellulosics such as sodium carboxymethylcellulose sodium, hydroxypropylcellulose, hydroxypropyl methyl cellulose, food starches such as cornstarch, potato starch, and/or rice starch, xanthan gum and combinationsthereof. In an aspect, these may be suitably employed as a treatment fordysphagia which comprises feeding a concentrate thickener compositioncontained within a food to a patient having the condition of dysphagia.The choice of industrial food thickener employed in the thickenerconcentrate may be, but does not have to be, specifically selected toprovide benefits over current products in terms of taste, clarity, andthe selection of beverages to be thickened.

In a preferred aspect, the thickener selected comprises xanthan gum.

As used herein the term “liquid food” includes a food, liquid inappearance, entirely or in part based on water, a liquid nutrient, foodcontaining unbound liquid, liquid medication or food.

The amount of thickener employed in a concentrate thickener will dependgreatly on the specific thickener chosen, its specific thickeningproperties, and the processing equipment employed. In general, theamount employed will be between about 1 and about 10% thickener byweight, although most typically the amount employed will be betweenabout 1 and about 5% thickener by weight.

As the concentration may vary depending on the equipment and thethickener employed, a sufficient quantity of thickener powder for theconcentrate thickener being prepared is admixed with water in a suitablemixing vessel. A preferred mixing vessel comprises a container which isof a size accommodating the amounts of thickener powder and waterdesired to be suitably mixed. The vessel typically is acommercially-sized tank, the particulars of which are not critical andmay or may not include a cover, a particular shape, the presence ofbaffles, and/or a heat jacket. Other suitable useful mixing vesselsinclude a drinking cup, bowls, household containers which can be open orclosed top, a kitchen top mixer system, as well as any suitably sizedcontainer which will accommodate the amount of water and thickener to besuitably admixed.

Generally, the temperature of the water is not critical to thepreparation of the concentrate thickener and may include, withoutlimitation hot, cold, or room temperature water. With some particularthickeners, the inherent properties will make the choice of temperaturemore critical than it is with others.

As necessary or desired, minor components such as acids, bases,acidulates, chelating agents, flavors, colors, vitamins, minerals,sweeteners, insoluble foods and/or preservatives may be incorporatedinto the thickener and water admixture at any appropriate point duringthe preparation. It is understood that such minor components will likelybe present in minor amounts and concentrations, i.e. a non-substantialamount as relates to thickening.

In an exemplary embodiment, depending on the specific admixing equipmentused and the appropriate handling of the materials the time needed foradmixing the thickener concentrate is in the range from about 2 minutesto about 180 minutes and preferably from about 5 minutes to about 60minutes although greater and lesser times may be employed if desired ornecessary.

Optionally, as necessary or desired, the thickener concentrate may betreated to provide shelf stability. Most commonly, but not limiting, thetreatment is heating in combination with one or more of the minorcomponents mentioned above.

The packaging of the thickener concentrate is not critical as long as itdelivers an effective amount of concentrate to thicken a liquid food toa thickness effective for a person afflicted with dysphagia.Illustratively, packaging may be totes, bins, foil pouches, buckets,bags, syringes or the like.

If desired, use of a thickener concentrate will facilitate in-linemixing and preparation of thickened beverages in a beverage dispenser orcontainer. Such a system would include a metering device and an in-linemixing system to dispense thickened beverages. It could also be designedto dispense thickened or non-thickened beverages at the turn of aswitch.

In an aspect, the thickener concentrate is an effective thickener forliquid foods.

An effective amount of the aforedescribed thickener concentrate isadmixed with a liquid food which illustratively is selected from atleast one of milk, human breast milk, cow's milk, soda, coffee, tea,juice (lemon, citrus, orange, apple), alcohol (beer, wine, or mixeddrinks with less than about 20% alcohol) water, nutritional supplements,mixtures thereof and the like or a soup, broth, or food puree and thelike.

As employed herein the term “juice” includes puree, fruit juicesincluding orange juice, vegetable juice and apple juice strained andunstrained, concentrated and fresh.

Suitable vessels to effectively admix the thickener concentrate and theliquid food include drinking cups, coffee cups, bowls, householdcontainers which can be open top or closed top, a kitchen blender, akitchen top mixer system, as well as any suitably sized accommodablecontainer which will accommodate the materials to be admixed. Suitableinstruments to carry out the admixing include forks, spoons, knives,hand mixers, kitchen blenders, kitchen top mixers, whisks, and any otherappropriate agitation devices. Particularly suitable mixing containershave a lid or cover that can be attached to the container to allow theliquid food and thickener concentrate to be shaken together withcontainment.

In an exemplary process, the amount of thickener concentrate employed inthe admixture is that amount which provides a thickened liquid foodwhich is capable of being consumed by effectively swallowing by a personafflicted with dysphagia.

In an exemplary process, the amount of time employed in the immediatelyaforedescribed admixing is in the range from about 0.01 to about 3minutes and preferably from about 0.01 minutes to about 1.5 minutes.

Advantageously the amount of mixing time is of an order of time suchthat staffing in hospitals, skilled nursing facilities, nursing homes,and/or retirement homes are able to more comfortably accommodate. Alsoadvantageously the thickened liquid food is fully thickened once theconcentrate is fully diluted. No standing time is necessary as thepolymer dissolution was completed during the preparation of theconcentrate. These invention advantages are improvements over thecurrent products which require a two step process during the preparationof the final foodstuff which combines mixing and standing time. Thesealso take from about three minutes and as long as about 30 minutes ormore to fully and properly thicken the liquid food.

An advantage with the inventive compositions is that they are safer toeat without adding any further liquid to them and they are safer toleave in the presence of persons with impaired mental judgment. Althoughcertainly very viscous, consumption of the thickener concentrate withoutdilution does not present a choking hazard. Dry powders put in the mouthand/or attempted to be swallowed before dissolving could present adanger to a patient with impaired mental judgment. In many facilities,open containers of powder are left on tables or in rooms or individualsized packets are served on trays. If a caregiver is somehow distracted,an impulsive eater, like those, as a non-limiting example, afflictedwith Huntington's chorea, could quickly try to consume the dry powder,at serious risk. Because they are completely hydrated, the compositionsof this invention face no such problems.

Another advantage of this approach to thickening liquid foods is theconsistency of preparation. When using dry powders for thickening athome or institutions, there are several factors which contribute to thevariability of preparations from a dry powder.

First, most of the thickeners currently used are agglomerated productsthat are measured by volume. Since balances are not commonly available,solutions are prepared via the most typical and convenient meansavailable—measuring the product by volume (i.e. 2 tablespoons per fourounces of fluid) with normal household measuring spoons. There is anunfortunate flaw in this approach because settling in the containerduring shipping and the breakdown of agglomerates from the scooping andleveling action of measuring each serving will tend to cause variabilityin the bulk density of the powder from the top to the bottom of thecontainer. Thickness is typically logarithmically related to thickenerconcentration so small changes in concentration can have largedifferences in the thickness achieved.

Second, the manner of addition is uncontrolled and varies. Poor productaddition leads to more clumping of the powder. This leads to lesscomplete hydration for a given amount of mixing.

Third, the mixing time is an uncontrolled yet highly relevant factor.Mixing longer achieves complete hydration. However, most people do notmix long enough to achieve complete hydration. There are otheractivities, duties and/or patients to attend to, so they stop mixingwhen the solution is “thick enough”. However, unhydrated particlescontinue to swell and thicken. This changes the final thickness as timepasses and can lead to substantially over-thickened liquid foods thathave to be eaten with a spoon rather than poured.

Fourth, hydration characteristics of thickeners from dry powderstypically vary in different fluid environments. For example, thepresence of calcium ions in a liquid food like milk may make it nearlyimpossible for a particular thickener to hydrate in a reasonable timeperiod even though it hydrates rapidly in water. Since each liquid foodto be thickened represents a slightly different environment, there maybe differences in thickness and in time to hydrate between differentliquid foods.

The thickener concentrates of this invention overcome theseaforementioned problems. The thickener concentrates of this inventionare delivered to the end user fully, completely, and totally hydrated,and will not settle or separate when shipped. Its density will notchange over time and is stable. Consequently the same volume ofthickener concentrate will thicken a liquid food to the same level ofthickness whether the thickener concentrate is from the top or thebottom of a container. Liquid foods thickened by a thickener concentratewill not continue to thicken after preparation. Since the thickener isalready hydrated in the thickener concentrate, any concern over thefluid environment and its impact on hydration time is eliminated. Thestep of preparing thickness concentrates is quite beneficial.

A radiological technique known commonly as the modified barium swallowis used to diagnose and to make therapeutic recommendations on thickeneddiets to those patients afflicted with dysphagia. Currently hospitals ornursing homes or mobile diagnostic units prepare the test solutions intheir own manner. There is little standardization on the thickness ofthese solutions. There are no means in place to ensure that the mealtimepreparations served to diagnosed patients actually are the samethickness as the test preparations.

The thickener concentrate compositions of the present invention providethe opportunity to link the thicknesses prepared during the modifiedbarium swallow to what is prepared in food service and/or bedside and/orat home. The thickener concentrate compositions of the present inventionreduce the variability of final thickness in different liquid foods andreduce the variability of mixing technique. The elimination of clumpingand mixing time factors will reduce the variability between what happensduring a modified barium swallow and in food service and/or bedsideand/or at home for actual consumption.

Another common diagnostic technique of dysphagia is the fiber opticendoscopic evaluation of swallow. In this technique, an endoscope isinserted through the patient's nasal passage into the throat to directlyobserve the patient's swallow function. In an aspect, thickeningcompositions of the present invention can be used to thicken testpreparations used in this evaluation technique.

Although many thickeners are suitable for use in the present invention,the preferred thickener is xanthan gum. Xanthan gum is manufactured andsold by CP Kelco of Wilmington, Del. USA as the Keltrol® family ofproducts, Rhodia Food Ingredients of Cranbury, N.J. as the Rhodigel®family of products, and Archer Daniels, Midland Company of Decatur, Ill.USA. Xanthan gum is a microbial polysaccharide produced by a pureculture aerobic submerged fermentation of xanthomonas campestris.Xanthan gum is comprised of a backbone of 1,4 linked D-glucose withtrisaccharide side chains on alternating anhydroglucose units. The sidechains are comprised of a glucuronic acid residue between two mannoseunits. Typically, xanthan gum forms cloudy solutions in water. Examplesof useful xanthan gums include those such as Keltrol®, Keltrol® F,Rhodigel®, Keltrol® T, Keltrol® RD, and Rhodigel® Clear xanthan gums.Xanthan gum is typically available as a powder of varying suitableparticle sizes.

As used herein the term “xanthan gum” includes xanthan gum and clarifiedxanthan gum in all different powder forms and mesh sizes.

In an exemplary process, xanthan gum and water are effectively admixedto provide a concentrate xanthan gum thickener having about 2% to about5%, specifically about 3.5% to about 4.5% and more specifically about3.6% to about 4.3% xanthan gum content. The xanthan gum concentrate hasthe visual appearance and physical consistency of a thick paste orjelly, similar to hair gel, lotions, and honey at about (72° F.) roomtemperature.

Employing the preferred xanthan gum concentrate to thicken liquid foodis advantageous in terms of flavor, and taste, thereby promoting betterhydration and nutrition. Employing clarified xanthan gum is alsoadvantageous in appearance. The current commercially available productscomprise starch and impart an off-flavor to many beverages. Thisdiscourages consumption of an adequate amount of liquids. Employing thepreferred compositions of this invention encourages greater consumptionof liquids by persons afflicted with dysphagia. Patients will drink moreand thereby maintain adequate hydration. This improves the patient'shealth, happiness, and lifestyle.

Although the compositions of the present invention are most useful andadvantageous to those with dysphagia, they have benefits in other areas.People who suffer from celiac's disease cannot tolerate foods withgluten in it. Gluten typically comes from grains like wheat or corn, andthey cannot use common household corn starch to thicken their foods likesoup. Other thickeners are recommended. Also gluten-free recipes forbreads and the like often specify the addition of xanthan gum due to itsability to keep breads moist. Again the most commonly availablesubstitutes are powders, which are difficult at best to properlydisperse and hydrate. Without proper dispersion and hydration, theeffectiveness of these powders is limited. But the use of a thickenerconcentrate is extremely effective because the thickener is alreadycompletely dispersed and hydrated.

Children are often attracted to novelty treats. With the addition ofsugar or other sweeteners, flavors, colors, and/or an insoluble novelty,in an aspect, the compositions of the present invention could be used asa novelty treat for children.

Although exemplary embodiments of processes are described herein,processes are not limited to such exemplary embodiments.

EXAMPLES OF THE INVENTION

Examples 1-33 following demonstrate that effective thickenerconcentrates can be prepared from different thickening agents.

In Examples 1-10 following, a 4% w/w solution of clarified xanthan gumwas prepared in water in the following manner: 22.47 g of clarifiedxanthan gum (composing of 89% clarified xanthan gum and 11% water) wasadded to 477.53 g of tap water under agitation. The solution was mixedfor about one hour and no undissolved particles or fish eyes werevisible.

In Examples 1-5 following, a 1% w/w solution of xanthan gum was preparedfrom the concentrate in the following manner: 50.0 g of 4% xanthan gumin water was added to 150.0 g of each fluid and agitated gently for lessthan 5 minutes. Each thickened liquid food was qualitatively analyzed tofind whether it was thick enough to be of honey consistency. Allthickened liquid foods were visually appealing and tasted better than acontrol made with a competitive starch product.

Example Liquid Food Honey Consistency? 1 Tap Water Yes 2 Apple Juice Yes3 Cranberry Juice Yes 4 Orange Juice Yes 5 Milk Yes

In Examples 6-10 following, the compositions of Examples 1-5 were mixedwith an equal unthickened portion of the same liquid food and werequalitatively evaluated whether they were more of a honey or nectarconsistency. All thickened liquid foods were visually appealing andtasted better than a control made with a commercially available starchproduct.

Example Liquid Food Honey Consistency? Nectar Consistency? 6 Tap WaterNo Yes 7 Apple Juice No Yes 8 Cranberry Juice No Yes 9 Orange Juice NoYes 10 Milk No Yes

In Examples 11-18 following, a 4% thickener concentrate was preparedwith clarified xanthan gum. The paste was divided into aliquots of 25 mLor 10 mL in plastic bags. The plastic bags were heat sealed and thepackets were heat pasteurized. Packets were emptied into the fluid at arate of one packet per 4 oz. of liquid food. Various agitation methodswere tried and the consistency was subjectively evaluated. All thickenedliquid foods were visually appealing and tasted better than a controlmade with a commercially available starch product.

Example Liquid Food Packet Size Agitation Consistency 11 Tap Water 10 mLFork Nectar 12 Tap Water 25 mL Fork Honey 13 Tap Water 10 mL ShakingNectar 14 Tap Water 25 mL Shaking Honey 15 Apple Juice 25 mL ShakingHoney 16 Orange Juice 25 mL Shaking Honey 17 Coffee 10 mL Fork Nectar 18Pepsi One 25 mL Shaking Honey

For Examples 19-26 following, a thickener concentrate ofcarboxymethylcellulose sodium was prepared by admixing 10 g ofcarboxymethylcellulose sodium with 490 g of tap water. The concentratewas admixed with a blender and allowed to stand for approximately 20minutes. No undissolved particles were observed. Portions of theconcentrate were admixed with water, apple juice, and cranberry juicecocktail for a few seconds with an electric blender. All admixtures werethickened after this mixing and no standing was required. Theirconsistency was then evaluated by their feel in the mouth and how theyflowed when poured on a flat surface.

Amount of Amount of Example Concentrate (g) Liquid (g) Liquid FoodThickness 19 10 120 Water Nectar 20 12 120 Apple Juice Nectar 21 15 120Cranberry Juice Nectar Cocktail 22 35 120 Water Honey 23 75 120 WaterPudding 24 41 120 Apple Juice Nectar 25 60 120 Apple Juice Honey 26 75120 Cranberry Juice Honey Cocktail

For Examples 27-33 following, a thickener concentrate of fine mesh guargum was prepared by admixing 10 g of guar gum with 390 g of tap water.The concentrate was admixed with a blender and allowed to stand forapproximately 50 minutes. No undissolved particles were observed.Portions of the concentrate were admixed with water, apple juice, andcranberry juice cocktail for a few seconds with an electric blender. Alladmixtures were thickened after this mixing and no standing wasrequired. Their consistency was then evaluated by their feel in themouth and how they flowed when poured on a flat surface.

Amount of Amount of Example Concentrate (g) Liquid (g) Liquid FoodThickness 27 30 120 Water Nectar 28 75 120 Water Honey 29 40 40 WaterPudding 30 34 120 Apple Juice Nectar 31 34 120 Cranberry Juice NectarCocktail 32 80 120 Cranberry Juice Honey Cocktail 33 60 90 Apple JuiceHoney

Example 34

This example demonstrates that the thickener concentrates of thisinvention have reduced changes in viscosity over time and that they haveless variability in final thickness. Eight ounces of honey consistencybeverages were prepared with a commercially available starch thickener,Thick-It® starch thickener (Precision Foods, St. Louis, Mo. USA), byfollowing the manufacturer's directions on the can. 5 tablespoons ofpowder was added to each beverage and mixed for a few seconds with awhisk. Each thickened liquid food was allowed to stand for at least 30seconds. The thickened liquid foods were prepared in water, apple juice,cranberry juice cocktail, prune juice and orange juice.

A thickener concentrate was prepared with 3.75% clarified xanthan gum,0.25% citric acid, 0.1% sodium benzoate, and 0.1% potassium sorbate.This was heat processed for shelf stability and packaged in 25 galiquots into foil pouches. Nine months later, two of these packets wereadded to 8 oz. of each of water, apple juice, cranberry juice cocktail,prune juice and orange juice. They were mixed with a kitchen whisk forless than 90 seconds.

The viscosity of all thickened liquid foods was monitored with aBrookfield RV viscometer at 50 rpm with the appropriate spindle. Thedata were indexed to a viscosity of 100 at the time the beverage wasready for consumption. In the case of Thick-It® starch powder thickener,this was after the 30 seconds of standing. With the thickenercomposition prepared with xanthan gum, this was immediately after mixingwas completed. The indexed viscosity data after 90 minutes is asfollows:

Thick-It ® Xanthan Starch Powder Concentrate Apple Juice 285 153.8Cranberry Juice Cocktail 397.3 120.3 Orange Juice 270.8 129.2 PruneJuice 166.1 112.1 Water 185.7 101.5 Mean 261.0 123.4 Standard Deviation92.1 19.8 St. Dev. as % of Mean 35% 16%

When thickened with the compositions of the invention, the thickenedliquid foods on average, increased in viscosity by only about 23%. Whenusing Thick-It® starch powder thickener, the viscosity increased by overabout 160%. The compositions of the invention show far less change inviscosity over time.

In addition, the standard deviation, a measure of the variability of theviscosities of the thickened liquid foods, was reduced more than in halfas a % of the mean. The variation in viscosity of different thickenedliquid foods when using the compositions of the present invention isreduced.

Example 35

The following example demonstrates the benefits of the preferredthickener concentrates in terms of preference, taste, and appearance. Byimproving these characteristics, patients will consume greaterquantities of beverage.

In this Example, fourteen human patients of a long-term care facilitywere offered water and orange juice thickened with a commercial product,Thicken Right (Manufactured by Diamond Crystal Specialty Foods USA). Inaddition, they were offered water and orange juice thickened withcompositions of the invention. A thickener concentrate was prepared with3.75% clarified xanthan gum, 0.25% citric acid, 0.1% sodium benzoate,and 0.1% potassium sorbate. This was heat processed for shelf stabilityand packaged in either 10 g or 25 g aliquots in foil pouches. Afterthree months, the packets were added to the liquid foods at a rate ofone packet per 4 oz. of liquid food and agitated with a whisk to achievethickening. Patients on a nectar-consistency diet were given liquidfoods thickened with the 10 g aliquots. Patients on a honey-consistencydiet were given liquid foods thickened with the 25 g aliquots.

After evaluating the beverages in several characteristics, the patientswere asked which product they preferred. Overall 21 of 28 times, liquidfoods thickened with compositions of this invention were stated as thepreferred liquid food. Thirteen respondents stated that they preferredthe water thickened with the composition of this invention and 8 of 14respondents preferred orange juice thickened with the composition ofthis invention. These results are statistically significant whenanalyzed with statistical software.

In addition, the patients' responses to various statements wererecorded. Their responses were analyzed with a paired t-test withstatistical software. The results showed statistically significanthigher ratings for liquid foods thickened with compositions of theinvention than those for Thicken Right. In no cases were Thicken Rightthickened liquid foods rated higher that those thickened withcompositions of the present invention. In such an analysis, the strengthof the statistical significance is represented by the p-value. A lowerp-value means stronger statistical significance. Typically, any p-valueof 0.05 or less is considered statistically significant. The questionsand the associated p-values were:

-   -   1. I would enjoy drinking this liquid food as part of my        everyday diet. (p=0.002)    -   2. The liquid food taste was pleasing. (p=0.005)    -   3. The liquid food appears appetizing. (p=0.006)    -   4. The liquid food appearance was pleasing. (p=0.000)    -   5. The liquid food looks like it should. (p=0.006)    -   6. The liquid food looks like the consistency intended.        (p=0.011)    -   7. The texture of this liquid food is smooth and palatable.        (p=0.004)    -   8. The liquid food has no unappealing smells. (p=0.014)    -   9. The liquid food has no lumps. (p=0.008)    -   10. The texture of this liquid food looks smooth. (p=0.014)

This demonstrates the very strong appeal of the present compositions todysphagia patients.

Example 36

In this example, fresh human breast milk was frozen, thawed andthickened. Thickened human breast milk compositions were prepared withtwo different thickeners. One was a xanthan gum thickener concentrateand the other was Thick-It® starch powder thickener. Four-ounce samplesof breast milk were mixed with the appropriate amount of each of theaforementioned thickeners to produce a honey-like physical consistency.Viscosity data was measured with a Brookfield RV viscometer at 50 rpmwith the appropriate spindle as time progressed after preparation. Thedata are presented in Table A below, where A is the breast milk fromhuman 1 and B is the breast milk from human 2.

TABLE A Viscosity (cP) Time (hour:min:sec) B Thick-It A Thick-It BConcentrate A Concentrate 0:01:00 1,183 774 798 0:02:00 3,544 880 — —0:02:30 772 812 0:05:00 2,048 160 790 814 0:07:30 968 57 804 820 0:10:00434 46 800 820 0:12:30 234 — — — 0:15:00 113 — 812 840 0:17:30 64 — — —0:20:00 49 — — — 0:30:00 — — 826 848 0:45:00 — — 820 848 1:00:00 — — 822842

FIG. 1. Tabulated viscosity data as a function of time in human breastmilk

With Thick-It® starch powder thickener, the viscosity of the breast milkfrom B decreased by 98.6% in 20 minutes and the viscosity of breast milkfrom A decreased by 96.1% in 10 minutes. With the thickener concentrate,the viscosity of the breast milk from B increased 6.2% in 60 minutes andthe viscosity of the breast milk from A increased 5.5% in 60 minutes.

FIG. 2 shows the actual viscosity data. FIG. 3 shows the effects whenthe results are indexed to the viscosity at time 00:00=100.

Example 36A

To further demonstrate the effectiveness of the xanthan thickenerconcentrate in human breast milk, the samples from Example 36 thickenedwith the xanthan concentrate were frozen. Six days later, the frozensamples were allowed to thaw in a refrigerator. Two days later they werewarmed to room temperature and their viscosity was measured again. Thesamples showed no signs of separation when the samples were opened. Theviscosity of the B breast milk thickened with the xanthan concentratewas 868 cP (centipoise) and the A breast milk thickened with the xanthanconcentrate was 920 cP (centipoise).

The xanthan gum thickener concentrate thickens human breast milk andmaintains the thickness without significant changes in consistency. Thisis true even when frozen for six days and refrigerated for another twodays. This is a dramatic improvement over existing technology wherethickness is not maintained for even 20 minutes.

Examples 37 and 38 demonstrate that the improved taste and appearance ofa xanthan gum concentrate increases the quantity of fluid consumed bydysphagia patients and dramatically improves their quality of life andtheir health.

Example 37

A 78-year old Parkinson's patient with a history of nearly a year ofnearly continuous lung infections had been advised to thicken his liquidfoods to avoid future infections. Because he found powder thickenersunpalatable, he was consuming virtually no liquid foods. This led topoor oral hygiene, which led to rapid bacteria growth in the mouth, andthick stringy saliva. The bacteria in the mouth was the suspected sourceof the lung infections.

A thickener concentrate was prepared with 3.75% clarified xanthan gum,0.25% citric acid, 0.1% sodium benzoate, and 0.1% potassium sorbate.This was heat processed for shelf stability and packaged in 10 galiquots into foil pouches. Initially water and iced tea was thickenedat a rate of one 10 g packet per 4 oz of beverage. Later, thecomposition was added to whatever beverage the patient wanted toconsume.

Within 3 days of first being offered liquid foods thickened with theabove composition, the patient was drinking 2 quarts of water per day.The patient has not had any new infections within 4 months of follow up.

Example 38

After a series of respiratory infections were linked to aspiration ofliquid foods, a 5 year old boy was placed on a diet with all liquidfoods thickened. However, he would not drink beverages prepared withpowdered starches for two reasons. First, he reported that he hated thetaste. Second, he reported that he hated the powder lumps. Because hewould not drink thickened liquid foods, his growth and nutritionalstatus suffered. He was first fitted with a naso-gastric tube to providesufficient liquid foods and to supplement his solids. Eventually agastrostomy tube was inserted. For over a year, he was fed liquid foodsthrough the gastrostomy tube 3-5 times per day to ensure properhydration and nutrition. During this time, he would not drink liquidfoods thickened with commercially available powders.

A thickener concentrate was prepared with 3.75% clarified xanthan gum,0.25% citric acid, 0.1% sodium benzoate, and 0.1% potassium sorbate.This was heat processed for shelf stability and packaged in 25 g and 10g in foil pouches.

Approximately 5 months after preparation, the 25 g pouches were used tothicken liquid foods for the boy to honey-consistency by adding them ata rate of one pouch for every 4 oz of liquid food. He began to drinkthickened liquid foods orally and his dependence on tube feedings beganto decrease.

After approximately 1 month, a new modified barium swallow was conductedthat concluded he could progress to nectar-consistency fluids. At thispoint he began using the 10 g pouches at a rate of one pouch per 4 oz ofliquid food. He continued to increase his oral liquid food intake anddecrease his need for supplementation through his tube.

After approximately another 4-6 weeks, supplementation through his tubewas no longer necessary and the tube was removed. At last contact, hecontinues to have all his liquid foods thickened with the compositionsof the present invention and continues to consume sufficient liquidfoods orally.

While the invention has been described in terms of various specificembodiments, those skilled in the art will recognize that the inventioncan be practiced with modification within the spirit and scope of theclaims.

1. A packaged aqueous concentrate thickener composition suitable for shipment to a home or institution of a patient having the condition of dysphagia and suitable for addition from its packaging to a liquid food for the patient at the home or institution in order to thicken the food and to facilitate consumption of the food by the patient, the packaged aqueous concentrate thickener composition consisting essentially of a fully hydrated thickener and water.
 2. A packaged aqueous concentrate thickener composition in accordance with claim 1 wherein said aqueous concentrate thickener composition comprises about 1% to about 10% by weight of thickener.
 3. A packaged aqueous concentrate thickener composition in accordance with claim 1 wherein said thickener is xanthan gum.
 4. A packaged aqueous concentrate thickener composition in accordance with claim 1 wherein the concentrate thickener composition consists of xanthan gum, water, and at least one preservative.
 5. A packaged aqueous concentrate thickener composition in accordance with claim 1 wherein the aqueous concentrate thickener composition is packaged in a container having a top and a bottom, and wherein the same volume of thickener concentrate will thicken a liquid food to the same level of thickness whether the thickener concentrate is from the top or the bottom of the container.
 6. A packaged aqueous concentrate thickener composition in accordance with claim 1 wherein the aqueous concentrate thickener composition is packaged in a tote, a bin, a pouch, a bucket, a bag, or a syringe.
 7. A packaged aqueous concentrate thickener composition in accordance with claim 1 wherein the composition includes a non-substantial amount as relates to thickening of at least one component selected from the group consisting of acids, bases, acidulates, chelating agents, flavors, colors, vitamins, minerals, sweeteners, insoluble foods and preservatives.
 8. A packaged aqueous concentrate thickener composition in accordance with claim 1 wherein said concentrate thickener comprises a non-substantial amount as relates to thickening of a preservative.
 9. A packaged aqueous concentrate thickener composition suitable for shipment to a home or institution of a patient having the condition of dysphagia and suitable for addition from its packaging to a liquid food for the patient at the home or institution in order to thicken the food and to facilitate consumption of the food by the patient, the packaged aqueous concentrate thickener composition consisting essentially of about 2 to about 5 percent by weight of a fully hydrated xanthan gum in water.
 10. A packaged aqueous concentrate thickener composition in accordance with claim 9 wherein the composition includes a non-substantial amount as relates to thickening of at least one component selected from the group consisting of acids, bases, acidulates, chelating agents, flavors, colors, vitamins, minerals, sweeteners, insoluble foods and preservatives.
 11. A packaged aqueous concentrate thickener composition in accordance with claim 9 wherein said concentrate thickener comprises a non-substantial amount as relates to thickening of at least one preservative.
 12. A packaged aqueous concentrate thickener composition suitable for shipment to a home or institution of a patient having the condition of dysphagia and suitable for addition from its packaging to a liquid food for the patient at the home or institution in order to thicken the food and to facilitate consumption of the food by the patient, the packaged aqueous concentrate thickener composition consisting essentially of about 3.5% to about 4.5% by weight of a fully hydrated xanthan gum in water.
 13. A packaged aqueous concentrate thickener composition in accordance with claim 12 wherein the xanthan gum comprises about 3.6% to about 4.3% by weight of the composition.
 14. A packaged aqueous concentrate thickener composition in accordance with claim 1 wherein the concentrate thickener composition consists of xanthan gum, water, and at least one preservative.
 15. A packaged aqueous concentrate thickener composition in accordance with claim 12 wherein the aqueous concentrate thickener composition is packaged in a container having a top and a bottom, and wherein the same volume of thickener concentrate will thicken a liquid food to the same level of thickness whether the thickener concentrate is from the top or the bottom of the container.
 16. A packaged aqueous concentrate thickener composition in accordance with claim 12 wherein the aqueous concentrate thickener composition is packaged in a tote, a bin, a pouch, a bucket, a bag, or a syringe.
 17. A packaged aqueous concentrate thickener composition in accordance with claim 12 wherein the composition includes a non-substantial amount as relates to thickening of at least one component selected from the group consisting of acids, bases, acidulates, chelating agents, flavors, colors, vitamins, minerals, sweeteners, insoluble foods and preservatives.
 18. A packaged aqueous concentrate thickener composition in accordance with claim 12 wherein the aqueous concentrate thickener composition is packaged in a pouch. 